Cleared Traditional

K882586 - A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

K882586 is an FDA 510(k) clearance for A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM, manufactured by A-Kem, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K882586 · A-Kem, Inc. · Chemistry device
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Aug 1988
Decision
46d
Days
Class 2
Risk

K882586 is an FDA 510(k) clearance for the A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on August 8, 1988 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A-Kem, Inc. devices

FDA 510(k) Submission Details - K882586

510(k) Number K882586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1988
Decision Date August 08, 1988
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIC Device Classification - Class 2, Special Controls

Product Code CIC Cresolphthalein Complexone, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIC Cresolphthalein Complexone, Calcium

All 90
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K882586.
CALCIUM TEST ITEM NUMBER: SR1009
K884986 · Em Diagnostic Systems, Inc. · Jan 1989
TECHNICON ASSIST(R) CALCIUM METHOD
K884433 · Technicon Instruments Corp. · Nov 1988
BIOTROL BILIRUBIN MONOREACTIF
K884480 · Biotrol, USA, Inc. · Nov 1988
CALCIUM
K880308 · Catachem, Inc. · May 1988
CALCIUM, CATALOGUE NUMBER 122-20
K881054 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
CALCIUM REAGENT SET
K880845 · Tech-Neal Scientific, Inc. · Apr 1988